Announcing the 2019 MedTech Regulatory Awards Recipients

The second annual MedTech Regulatory Awards will take place the evening of September 23rd in Philadelphia. This year, the night will focus on the overall outstanding contributions of regulatory professionals and their work leading to achievements in approvals. While receiving many great nominations, the 2019 MedTech Regulatory Awards chooses to award the regulatory achievements of the following companies: Optos Inc. (Scotland), ACell Inc. (USA), and Mazor Robotics Inc. (Israel). Visit our pageto learn more and register for the event.

2019 MedTech Regulatory Award

To recognize exceptional effort made by regulatory affairs professionals and their teams in bringing many advanced medical technologies and practices to patients and physicians around the world in recent years. This award was open to regulatory affairs professionals and teams from manufacturing companies.

Presented to: Optos Inc. Regulatory Team

Graham McLeod, Alan Leitch, Holly Cribbes, & Rachel Reay

The Optos Regulatory Team is to be awarded the MedTech Regulatory Award for their success in becoming the world’s manufacturing leader in ophthalmology products. Optos is consistently bringing new products to new markets with their products currently registered in more than 40 countries and with over 10,000 devices installed worldwide. In 2018, Optos registered the P200TE Monaco, the only ultra-widefield retinal imaging with integrated OCT™. This breakthrough product was registered in 20 countries including USA, Canada, Japan, Malaysia, Singapore, Taiwan, Thailand, Saudi Arabia, UAE, Argentina, Colombia, Peru and the EU. Optos’ high-resolution optomap images display approximately 82% or 200° of the retina, something no other device is capable of doing in a single capture.

Currently, Optos has over 20 on-going registrations in process and continues to strive towards providing the best retina devices by utilizing the latest technology to manufacture new products and software. Their latest approval in the US market during 2019, was receiving FDA 510k clearance for the P200TxE device, this August.

2019 MedTech Impact Awards

To recognize the global impact of specific MedTech products and the regulatory team behind its universal market access. This award was open to regulatory affairs professionals and teams from manufacturing companies. This year we have two outstanding companies being awarded the MedTech Impact Award.

Presented to: 2018 ACell Inc. Regulatory Team

The 2018 ACell Regulatory Team is to be presented with the MedTech Impact Award for creating a lasting global impact in 2018 through registering multiple innovative products in both the USA and Canada. The team worked extremely hard to bring ACell products outside of the American market for the very first time, allowing the company to successfully enter the Canadian market with the Cytal Wound Matrix, MicroMatrix, and Gentrix Surgical Matrix product lines. All three product lines are classified as the highest risk devices (Class IV) in Canada.

Within the same year, the ACell Regulatory Team also received FDA clearances for the Cytal Wound Particulate and the Gentrix Surgical Matrix & Gentrix Surgical Matrix Hiatal. The Gentrix Surgical Matrix Hiatal being the first hernia product with hiatal/diaphragmatic specific indications and first Hiatal Hernia specific product cleared under the OWV product code since 2014. These products are equally difficult to clear in the USA as the surgical mesh is surrounded by complications with adhesions and mesh erosion. The Gentrix Surgical Matrix products offer patients safe and effective devices for complex hernia repair in the USA and Canada.

Presented to: Mazor Robotics Inc. Regulatory Team

Shiran Confonti, Marina Hefetz, Yael Liebes Peer, & Anat Alexandroni

The Mazor Robotics Regulatory Team will be awarded the MedTech Impact Award for its breakthrough advancements in robotic spine surgery. Mazor Robotics was the first company to commercialize robotic health care in the spine field. The SpineAssist was registered by the FDA and received CE mark in 2004, . This device made waves as the first-ever FDA approved robotic guidance system for spinal surgery. More recently, Mazor Robotics has launched additional advanced products incorporating its core technology, the Mazor X Stealth Edition, and the Mazor Robotics Renaissance® Guidance System. The Mazor X Stealth Edition combines advanced software, robotic guidance technology, navigation and instrumentation to provide accurate trajectory guidance for surgical procedures and was approved by the USA FDA in November 2018 and launched in the US in early 2019. The Renaissance® Guidance System is approved worldwide and has the clinically proven ability to vastly positively impact execution and outcomes for spine surgeries.

Mazor Robotics’ products have been used in over 40,000 procedures, world-wide. The company went public in the US in 2013 and was acquired by Medtronic, the world’s largest medical device company.

The MedTech Regulatory Awards are hosted by the Arazy Group Consultants. Since 1998, Arazy Group has been providing customized registration and license management solutions to medical and IVD device manufacturers.

In 2013, Arazy Group launched LICENSALE.COM® – Global Medtech Registration System, a cloud-based solution that streamlines, simplifies, and expedites the approval process for all types of MedTech and IVD devices in over 125 countries. LICENSALE.COM® is in use by small start-up to big top multinational MedTech manufacturers.